Metallizing Forfeiture Post-Helsinn

The following guest post is by Daniel Taskalos. After reading his 2013 Stanford Technology Law Review article on Metallizing Engineering post-AIA, I asked Mr. Taskalos to revisit those issues here in Patently-O. – DC

The critical issue in Helsinn was whether the post-AIA definition of prior art requires public disclosure of the details of an invention in order to trigger the on-sale bar. In the AIA, Congress revised § 102—otherwise known as the “novelty provision.” As revised, the new novelty provision states:

(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.

While the AIA maintained the pre-AIA language of “patented,” “described in a printed publication,” “in public use,” and “on sale,” it added the emphasized clause above (the “catch-all clause”). The AIA does not provide any elaboration on the import of the catch-all clause, leaving many to wonder exactly what its presence means for the interpretation of the other, well-known categories of prior art.

Since its enactment in 2011, scholars have debated the effect of the catch-all clause on the “public use” and “on sale” statutory bars.* Helsinn asserted that the catch-all clause modifies prior-art categories such that only disclosures that publicly disclose the details of the invention qualify as prior art. Advocates like Helsinn contend that the intention of Congress was to overrule “secret” use and sale decisions, like Metallizing Engineering.

Others, including Teva, argue that the addition of the catch-all clause does not invalidate the years of case law interpreting “public use” and “on sale.” These advocates contend that interpreting the catch-all clause to impose a “public” requirement would be a foundational change to the purpose and rationale for the public use and on sale bars support—in the absence of a clear repudiation by Congress of the pre-AIA law.

*The number of articles discussing both sides of the debate is far too numerous to provide a full list. You can find a few of these articles listed here.

The facts of Helsinn presented a unique situation in which to consider this important question. Helsinn sued Teva for allegedly infringing four patents directed to a formulation of palonosetron for reducing chemotherapy-induced nausea and vomiting (“CINV”). All the asserted claims covered a specific palonosetron amount in a solution—0.25 mg. The parties agreed that the critical date for all four patents was the same—but different laws were implicated by the patents. Three of the patents were governed by the pre-AIA patent laws, while the last patent fell under the AIA.

Teva alleged that Helsinn’s asserted patents were invalid under § 102. The conduct in question concerned an agreement entered into by Helsinn with another party to market and distribute Helsinn’s palonosetron formulation. Almost two years before the critical date, Helsinn agreed with MGI Pharma, Inc., that MGI would market and distribute one or more formulations of palonosetron, contingent on approval by the FDA. The agreement identified the 0.25 mg dosage as one of the potential formulations to be purchased and sold. Although the existence of the deal was made public (through a required SEC filing), the specific formulation details were redacted.

Thus, the district court faced analyzing the same conduct under two sets of laws: pre-AIA and post-AIA. Under either, however, the same two-prong framework explicated in Pfaff v. Wells Electronics applied: the on-sale bar is triggered where before the critical date (1) there is a sale or an offer for sale and (2) the claimed invention was ready for patenting. Under the Pfaff framework, the district court found that the distribution agreement constituted a sale with respect to the three pre-AIA patents. But the district court interpreted Congress’ addition of the catch-all clause as a modification to the “on sale” category that placed a public requirement on the disclosure itself. The district court found that under the AIA, a § 102-triggering sale must publicly disclose the details of the invention; a public sale that did not disclose the claim limitations was insufficient.

The Federal Circuit reversed this decision and provided an analysis may prove instructive in future cases concerning public uses and other non-informing disclosures. In its opinion, the Federal Circuit noted that the support for Helsinn’s argument that § 102’s requirements changed with Congress’ addition of the catch-all phrase rested outside of the text of the amended provision; Helsinn relied primarily on floor statements by a few individual members of Congress.

The Federal Circuit noted that those floor statements appeared to show “at most” an intent to do away with case precedent concerning “public use” cases, not “on sale” cases. According to the Court, the only “precedent” cited by the Congressmen were cases in which the invention was used in public, but that use did not disclose to the public the details of the claimed invention. E.g., Egbert v. Lippman; Beachcombers International v. Wildewood Creative Products; Jumpsport, Inc. v. Jumpking, Inc. Moreover, the Federal Circuit explained that even assuming the statements could be stretched to cover sale cases as well, the “secret sale” cases “were concerned entirely with whether the existence of the sale or offer was public,” not whether the details of the invention were disclosed. Thus, the Court found the floor statements were of little support for a different interpretation of the statutory meaning of “on sale” under the AIA.

The Federal Circuit further found Helsinn’s argument unpersuasive because imposing a publicity requirement would “work a foundational change in the theory or the statutory on-sale bar.” In fact, the Federal Circuit noted that the issue of whether to impose a publicity requirement was exactly the situation in Pennock v. Dialogue, in which Justice Story created the on-sale bar. In Pennock, Justice Story found that allowing a patent to stand after a sale that did not disclose the claim limitations “would materially retard the progress of science and the useful arts, and give a premium to those who should be least prompt to communicate their discoveries.” Relying heavily on its prior case law, the Court also explained why such a publicity requirement has never been considered necessary. The Federal Circuit concluded by hold that at most, the catch-all clause just requires that the sale must put the patented product in the hands of the public,* not that it must be informed of all the limitations of the claim.

*Of course, the Federal Circuit did not mean that the product must be explicitly in the hands of the public. As discussed in the opinion, “our prior cases have applied the on-sale bar even when there is no delivery, when delivery is set after the critical date, or, even when, upon delivery, members of the public could not ascertain the claimed invention.”

Looking at the Federal Court’s reasoning in Helsinn and The Medicines Co. v. Hospira, Inc., that Metallizing Engineering may remain good law under the AIA. As the Federal Circuit made clear, it does not view the floor statements in Congress as evidencing a clear intent to overturn the “on sale” precedent, instead “at most” supporting an argument that the intent was to overturn the “public use” case law. In The Medicines Co., the Federal Circuit referred to Metallizing as an “on sale” case: the conduct at issue in Metallizing was the sale of performing a particular claimed process for compensation before the critical date, i.e. activity triggering the on-sale bar. Thus, the Federal Circuit would likely find mere floor statements to be of little relevance to a factual situation similar to Metallizing. Moreover, as the Federal Circuit identified, the law regarding “secret sales” has always been concerned with whether the existence of the sale itself was publicly disclosed—not the details of the invention. There is no indication in Metallizing that the sales at issue were not publicly known, so the same rationale from Helsinn should apply.

In Helsinn, the Federal Circuit anchored its holding on the fact that imposing a requirement that a triggering sale disclose the details of the invention directly contradicts Justice Story’s reasoning in Pennock for creating the on-sale bar. As Justice Story saw it, to allow an inventor to exploit commercially his or her invention for an extended period and still maintain the ability to seek patent protection would undercut the “progress of science and the useful arts” and promote undesirable behavior. This principle has been consistently reiterated by the Federal Circuit. See The Medicines Co.; Atlanta Attachment Co. v. Leggett & Platt, Inc. (“The overriding concern of the on-sale bar is an inventor’s attempt to commercialize his invention beyond the statutory term.”). The aim of discouraging the inventor from improperly extending the monopoly was one of the underlying reasons behind Judge Learned Hand’s decision in Metallizing. Thus, it is possible that the Federal Circuit may find Metallizing to remain applicable after the AIA, despite the reduced ability for such conduct under the first-to-file concept of the AIA.*

*This is one argument raised in support of the view that the AIA explicitly overrules Metallizing. Under the first-to-invent approach, this type of secret commercialization provided a greater incentive because even if another filed a patent on the claimed invention prior to the commercial exploiter, the exploiter could, in theory, establish prior invention and obtain the patent. As prior invention is no longer a valid argument under first-to-file, the incentive to secretly exploit an invention is diminished. However, the fact that success may be more difficult does not, in and of itself, mean the forfeiture doctrine no longer has value or applicability. As long as one person is still able to commercially exploit his or her invention in a manner like that in Pennock or Metallizing, the reasoning for the doctrine would still apply.

The recent Supreme Court decision in TC Heartland LLC v. Kraft Food Grp. Brands LLC also provides support for the continued relevance of Metallizing. See No. 16-341 (May 22, 2017). At issue in TC Heartland was the impact of Congressional amendment of the general venue statute (28 U.S.C. § 1391(c)) on the interpretation of the patent venue statute that was not amended (28 U.S.C. § 1400(b)). The patent venue statute has remained unchanged since the Supreme Court interpreted its scope, holding that a domestic corporation only “resides” for purposes of venue in a patent infringement action in its state of incorporation. See Fourco Glass Co. v. Transmirra Products Corp. (1957). However, after Congress amended the general venue statute in 1988, the Federal Circuit held that Congress’s amendment also changed the scope of where a corporation “resides” under § 1400(b) (although § 1400(b) remained unchanged). See VE Holding Corp. v. Johnson Gas Appliance Co. (1990). In TC Heartland, the Supreme Court reversed the Federal Circuit’s ruling in VE Holding, emphasizing that “[w]hen Congress intends to effect a change [to the statutory meaning of legal language], it ordinarily provides a relatively clear indication of its intent in the text of the amended provision.”

Accordingly, the TC Heartland decision can be interpreted as requiring clear congressional intent within the text of an amended provision itself to modify the settled meaning of statutory language. Such an interpretation would further undermine the persuasiveness of the minimal floor statements discussed in Helsinn, given that those statements were by individual senators, put forth their interpretations of post-AIA § 102, and are not included within the text of the AIA. Moreover, the Federal Circuit in Helsinn appears to have found the catch-all clause to not be a “clear indication if [Congress’s] intent in the text of the amended provision” to change the interpretation of “on sale” in the statute. In light of the large amount of scholarly debate on the meaning of the clause, it seems unlikely that the Supreme Court would disagree with the Federal Circuit’s apparent determination.

After Helsinn, it appears that on-sale bar precedent has survived the AIA. Applying the Court’s reasoning, and in view of other recent cases such as The Medicines Co. and TC Heartland, it appears the Metallizing Engineering precedent may also have survived the AIA, at least for now. However, there is still the possibility that the Federal Circuit may take the opportunity presented by the ambiguity caused by the catch-all clause to revisit the ultimate decision in Metallizing. Although the Federal Circuit may consider Metallizing to be an “on sale” case, Judge Hand’s opinion does rely on principles underlying both the “public use” and “on sale” bars. As such, the forfeiture doctrine of Metallizing would appear to be an extra-statutory bar, not falling within either the “public use” or “on sale” categories entirely. Because of this, some have questioned whether Judge Hand’s decision is actually correct. See Dimitri Karshtedt, Did Learned Hand Get It Wrong?: The Questionable Patent Forfeiture Rule of Metallizing Engineering, 51 Vill. L. Rev. 261 (2012). Moreover, although the Federal Circuit was not persuaded as to the “clear indication” of intent to change the meaning of “on sale” as advocated by Helsinn and others, that is not to say the Supreme Court would hold the same.

Daniel Taskalos is an intellectual property associate at Sheppard Mullin Richter & Hampton LLP. His practice covers a range of issues, including litigation and counseling.

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43 thoughts on “Metallizing Forfeiture Post-Helsinn”

Supported by the caselaw in the first-cited-above legal article is the following here: “Judge Hand’s opinion does rely on principles underlying both the “public use” and “on sale” bars [but not the statute itself]. As such, the forfeiture doctrine of Metallizing would appear to be an extra-statutory bar, not falling within either the “public use” or “on sale” categories entirely.”
As such, the real issue may not be the statutory modification of Section 102 by the AIA, but rather the attitude of the Sup. Ct. to two different and conflicting policies. First, their recent expression of dislike for equitable estoppel, at least for suit-delay-laches. But this will be counteracted by their highly unlikely acceptance of a company being able to commercially practice a secret manufacturing process for many years, and yet then still obtain a patent for that same process for 20 more years. [The latter would be the result of overruling Metallizing.]

Paul, allowing anybody to practice an invention commercially longer than the grace period and still obtain a patent not only violates Metallizing, it violates Pennock v. Dialogue.

As in the case of in TC Heartland where the Supreme Court continue to follow Fourco despite somewhat overwhelming evidence that Congress understood that VE Holdings was the law in its 2011 revision of the venue statutes, it is unlikely that the Supreme Court will consider its holding in Pennock overturned unless the statute can be read in no other way.

As others have pointed out, there was an effort by many to get “on sale” out of the statute entirely. That effort was not successful, and as an end run, there was an effort to limit its effect by the so-called colloquies to which anon so often refers.

I think the Supreme Court is going to view legislative history varying clear, at best, on Congress’s intent.

“The new § 102 also sweeps away a large body of patent law. All the “loss of right to patent” provisions of pre-AIA § 102 have been repealed…

In light of the AIA’s repeal of all “loss of right to patent” provisions based on secret activities from § 102, those words have been removed from the title of § 102.”

“All” – used twice does not mean “some” – specifically, does not mean only “sales” or “offers for sale,” and certainly does not permit the judicial branch to set about “re-interpreting” in order to attempt to preserve policy views from the pre-AIA version of the law.

The changes to 102 were meant to be – and it is fully know that – a radical overhaul of the law of 102. As such, the view to attempt to have Congress recognize every PRE-AIA judicial wrinkle is a legal-logic fallacy. Put simply: in such a case as a noted total overhaul, Congress does not have to attempt to “put into the record” every single permutation of judicial adjustments through various cases.

However, Pennock is the law — controlling law, on “on sale.” It is a Supreme Court case. Congress brought “on sale” into the statutes in 1836 in response to this case.

The question of overrule is whether Congress intended to overrule Pennock, not Metallizing. To that end, there was no discussion of Pennock at all by any Congressmen or Senator that I know of. It is as if everyone involved in that process never even heard of Pennock.

Anon, you are reviewing Matal tome on the history of the AIA legislative process. Perhaps you can enlighten us on this point.

However, anon and I have been discussing Pennock here on Patently-O for years now, and it is clear that Pennock has become more widely known because of that discussion. It is not by accident, I think, that the reasoning of the Federal Circuit focused on this Supreme Court case written by none other than the legendary Story.

Paul, there is no doubt that the Federal Circuit has adopted the principles of Metallizing. As well, Supreme Court has cited Metallizing with approval.

But neither controls the Supreme Court as does Pennock. We just learned in TC Heartland how much respect the Supreme Court gives to lower court decisions that are inconsistent with controlling Supreme Court precedent that has not been clearly repealed by statute.

Pennock is the law and it must be followed even by the Supreme Court. That is why the Federal Circuit had to cite and rely on Pennock. That is also why Learned Hand decided Metallizing the way he did. He relied on Pennock.

And, the way the Federal Circuit treated VE Holdings in TC Heartland tells one quite a bit about how the Supreme Court will treat Patlex and MCM Portfolio LLC in view of McCormick Harvesting, a case directly on point and which controls the Supreme Court decision-making because it has not clearly been overturned by statute, nor can it be because McCormick Harvesting was based upon constitutional authority. Even the Patlex court agreed on this point.

On the contrary, I had complemented Ned on directly and constructively presenting constitutional arguments in their proper legal forum, not just in blog comments. They have been supported by case citations what he considers to be controlling authority [not by attempted insults]. I was entitled to my own, and correct, opinion that they would not succeed. My response here was obviously merely to the overstatement that “Metallizing is not the law.” It most certainly is the law, unless and until a Sup. Ct. decision overrules the Fed. Cir. cases I cited.

Your Republikkkan party, folks. Gotta line up behind the imbecile and prop him up, regardless of how ridiculous it makes you look. Desperate rich white assholes, entitled and oh-so-bitter, will do and sayliterally anything to cling to the last vestiges of their steadily shrinking power. Remind you of any particular segment of the patent bar? Oh, of course it does. And it should because many of the same dynamics are in play (absent the overt r@ ci sm).

I wonder if the Arizona Sons of the Confederacy (totally not r@ cists! they just like history! LOL) who voted a bitter 80 year old, objectively senile television chair warmer into office for a six year term (!) are having second thoughts about that.

Not sure what else to call them that would satisfy your PC sensitivities, snowflake.

You do remember that Mango Hairball and his party rode to “victory” with a combination of minority voter suppression, gerrymandering, and direct appeals to white supremacists, right? You remember how Mango Hairball got those people exited right? The birth certificate business? You remember that, right?

I mean, you haven’t forgotten that already, have you? I mean, you’re a very serious person with your ‘protest vote’ and all. So you must remember this quite well. Let everybody know.

I’ll say it again: you’re either an adult who can plainly see and admit what this imbecile in the oval office has done and why, OR you’re an ign0r amus OR you’re an @ssh0le who wants to pretend that it’s not going on because (1) it personally benefits you or (2) you enjoy watching the least empowered people suffer, OR a combination of the last two categories.

In a nutshell, the FBI is not independent and is subject to the president’s direction. The present had full power to order Comey to stop investigation Flynn over his alleged misstatements regarding his post election contacts with the Russian ambassador.

Furthermore, Dershowitz stated that (loudmouthed, misinformed, arrogant, politically motivated, ignoramus) pundits, in their single-mind pursuit of the president, are jeopardizing the civil liberties of us all to the extent they are not telling the truth about the state of the law.

This is a nice post, worth re-reading a few times. I think it’s informative to look at the exact “floor comments” that were made and cited by the CAFC. I had already commented on this decision in another thread so I’ll re-post those comments below (with minor edits):

The big problem for the patentee in this case was that the existence of the patentee’s contract to sell the product (that was later patented) was publicized before the critical date. The patentee’s best counter-argument, I think, was that the specific dosage element of the claim was not publicly disclosed in the otherwise publicized agreement regarding the sale. The CAFC addresses this lack of disclosure in a manner that is not terribly compelling, even implying (in a footnote on page 26) that the element was somehow “inherently” disclosed by virtue of the agreement relating to the incompletely described product. To support its conclusion, the CAFC also collapses together cases involving fact patterns that are quite different from the facts of this particular case (e.g., the CAFC relies on cases where a product that “secretly” embodied the claim elements was actually commercialized and sold to the public and glosses over the policy differences — not to mention congressional testimony — that might suggest a different result where the agreed upon future sale of an undisclosed invention is publicized).

If we take the reasoning of this case to the limit, it suggests that publicizing on date X the existence of an agreement between company A and B wherein B “agrees to buy every useful article that A makes” — with no other information provided — would represent an “on sale bar” destroying A’s right to patent anything that was “ready for patenting” at date X. Seems a bit extreme …

With respect to the types of sales that were not intended to be post-AIA bars to patenting, at least as understood by Leahy and Kyl:

Leahy: [S]ubsection 102(a) was drafted in part to do away with precedent under current law that private offers for sale or private uses or secret processes practiced in the United States that result in a product or service that is then made public may be deemed patent-defeating prior art. That will no longer be the case.

Kyl: [T]he current on-sale bar imposes penalties not demanded by any legitimate public interest. There is no reason to fear ‘commercialization’ that merely consists of a secret sale or offer for sale but that does not operate to disclose the invention to the public. . . . The present bill’s new section 102(a) precludes extreme results such as these . . . .

Does this decision include pre-filing sales where the invention isn’t disclosed to the seller or doesn’t exist yet?

Could Helsinn have prevailed if they hadn’t disclosed the invention to MGI Pharma?

Many companies will have contracts with suppliers to purchase products on an ongoing basis. Inventions may be made in relation to those products and form part of the purchased products. Does this decision mean any patents filed for such inventions are invalid as they will be considered ‘on sale’ as soon as they are devised?

Not sure that this rehash will advance the fractured state of views on the topic…

But with Mr. Mattal’s ascension, I am re-reading yet again his two part tome on the AIA. Right off the bat, footnote 7 may shed light on this thread’s subject:

“Floor statements are not given the same weight as some other types of legislative history, such as committee reports, because they generally represent only the view of the speaker and not necessarily that of the entire body.

However, floor statements by the sponsors of the legislation are given considerably more weight than floor statements by other members . . . .”